Analyst, Product Surveillance III

Our client, a medical device organization is seeking a Analyst, Product Surveillance III to join their team. As a Analyst, Product Surveillance III, you will be part of the Quality organization supporting Product Surveillance and Complaint Handling teams. The ideal candidate will have a strong commitment to quality and compliance, the ability to independently investigate complex complaint records, and the drive to turn data into actionable post-market insights which will align successfully in the organization.

Job Title:
Analyst, Product Surveillance III

Location:

Alameda, CA - Onsite role
Duration: 6 months

Pay Range: $50-$55/hr on W2
Need a candidate with a minimum of 5 years of post-market surveillance experience within the medical device industry.

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• Independently evaluate, investigate, document, and close complex medical device complaint records. t
• Serve as a subject matter expert for complaint handling procedures, complaint closure decisions, regulatory requirements, and documentation standards. t
• Support global vigilance reporting, adverse event reporting, and reportability assessments. t
• Perform detailed quality reviews of complaint files to ensure compliance, documentation accuracy, consistency, and data integrity. t
• Analyze large complaint and post-market surveillance datasets to identify trends, detect emerging product performance signals, support risk assessments, and drive data-based decision making.

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• 5-8 years of medical device complaint handling or post-market surveillance experience. t
• Strong working knowledge of 21 CFR Part 820, Complaint Files (198), 21 CFR Part 803, ISO 13485, ISO 14971, EU MDR, and medical device quality systems. t
• Demonstrated experience independently evaluating, investigating, documenting, and closing complex medical device complaints. t
• Experience supporting adverse event reporting, complaint investigations, CAPA activities, complaint trending, risk assessments, and regulatory decision making. t
• Advanced proficiency with Microsoft Excel (pivot tables, advanced formulas, Power Query, data modeling, and data analysis techniques) and experience using SQL, databases, Salesforce, complaint handling systems, eQMS, and business intelligence/reporting tools.

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• Opportunity to be a technical leader in complaint evaluation and closure decisions while strengthening post-market surveillance outcomes. t
• Chance to apply advanced analytics to detect emerging signals, support risk assessments, and improve proactive quality decisions. t
• Role that combines rigorous documentation with data-driven reporting to support management review and continuous improvement. t
• Collaboration across cross-functional teams including Regulatory Affairs, Medical Events, Engineering, Quality Compliance, Track & Trend, Data Analytics, and Customer Service. t
• Visibility into regulatory inspection readiness through support of internal audits, management reviews, and health authority inquiries.

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• Medical t
• Dental Plan t
• Vision Plan t
• 401(k) t
• Weekly Pay